Institutional Biosafety Committee (IBC) Services


Advarra® provides comprehensive review and oversight of clinical trials involving genetically engineered gene therapy and vaccine research. Leverage the world’s largest integrated IRB and IBC service, combined with the most comprehensive Gene Therapy Ready site network, to move your clinical trials forward—faster.

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IBC review and oversight are essential for mitigating risks to study participants and researchers conducting clinical trials involving genetically engineered treatments and vaccines. Sites are required by NIH Guidelines to have IBC oversight if they are conducting research involving:

  • Recombinant DNA (rDNA), including messenger RNA (mRNA), synthetic nucleic acid (sDNA) molecules, or other genetically engineered treatments
    AND
  • Either receiving NIH funds or are conducting NIH-funded studies involving rDNA or sDNA

This includes sites outside of the United States. Even if there are no NIH funds involved, IBC review is a best practice. Privately sponsored studies routinely employ Advarra biosafety services to enable them to qualify for NIH funding, to support third-party regulatory requirements, or for enhanced research safety oversight. NIH Guidelines state “individuals, corporations, and institutions not otherwise covered by the NIH Guidelines are encouraged to adhere to the standards and procedures set forth” in the Guidelines (Section IV-D-1).

Visit the materials required for submission page to learn about the submission process and requirements.

Advarra Provides IBC Collaboration Without Complexity:

  • Coordination of concurrent reviews to deliver efficient, time-saving IBC and IRB reviews for all participating research sites
  • Rapid review through our Gene Therapy Ready site network
  • Custom biosafety consulting
  • Global support (we can provide NIH OSP based IBC review for sites worldwide)

Advarra IBC Services Support Research and Clinical Trials Involving:

  • Recombinant DNA
  • Synthetic nucleic acid molecules
  • mRNA engineered vaccines
  • Genetic engineering/gene therapy
  • Infectious microorganisms
  • Hazardous biological materials
  • Non-clinical plant and animal research

Local IBC Submission Support with IBC-Ready™

With IBC-Ready, Advarra can help reduce confusion and administrative burden by coordinating with the sponsor, site personnel, and local IBC(s). Advarra’s experts can help complete local IBC forms accurately and efficiently, regardless of the IBC of record.

  • Decrease timelines for local IBC submission and review
  • Eliminate confusion for investigators and study coordinators unfamiliar with IBC questions
  • Coordinate submissions for all local IBCs through a single entity
  • Service provided by biosafety professionals experienced in local IBC requirements and processes

Get Your Site Gene Therapy Ready?

Is your site ready to accept gene therapy and mRNA engineered vaccine research?

Join GTR Network

Submit a Study

The Advarra IBC portal simplifies study submission and reporting.

  • Submit a new study, amendment, or continuing review material and other reports
  • Communicate with the committee and support staff
  • Access approval documents

IBC Portal Log In

Become a Member

Advarra is seeking IBC committee members, community members, site inspectors, and consultants across the US and Canada to assist on a part-time basis with IBC reviews and biosafety-related projects.

Join IBC

Our IBC Services Include:

IBC Setup and Registration Support

  • Establishment of local biosafety committee administered by Advarra
  • Recruitment and staffing of qualified personnel
  • Implementation of industry-leading laboratory safety procedures
  • Management of regulatory registration

Protocol Review and Approval

  • Review of research protocols
  • Issuance of regulatory approvals
  • Ongoing monitoring and support solutions
  • IBC compliance and management
  • Year-round compliance management
  • On-demand review services
  • Site audit capabilities
  • Compliance reporting to NIH

Education, Training, and Operations Consulting

  • Research staff training
  • Laboratory safety
  • Biohazard education
  • Protocol, SOPs, and ICF consulting

Turnaround Time

Turnaround can depend on a site’s experience with and preparation for IBC review. Sites that are a part of Advarra’s Gene Therapy Ready network have an existing IBC and prior experience with human gene transfer studies. These sites can often be reviewed and approved for a new study in a few days, rather than 8-12 weeks from submission to IBC review and site inspection.

Institutional Biosafety Committee Reviews 101

Download the handout

FAQ

Want more information about the role of IBCs, requirements and the Recombinant DNA Advisory Committee (RAC) review process?

Read our FAQ

mRNA and Its Role in Clinical Research

Read the blog